Abstract
Background: The lack of proven effects of postoperative adjuvant chemotherapy in gastric cancer stimulates new therapeutic approaches. In vitro studies applying different kinds of interferon to renal cell carcinomas, however, indicated (as did clinical studies) its antitumor activity, but there is no experience so far about the effects of interferon on gastric cancer. Methods: 44 patients following curative resection of advanced gastric cancer were included in this prospective-randomized phase III pilot trial. 23 patients were allocated to the therapy group and treated with 4×106 units beta-interferon and in addition with 2x500 mg acetylic salicylate over a period of 30 days. The postoperative course was compared with that of 21 patients who received acetylic salicylate only. Results: Therapy-related side effects were observed in 13/23 patients of the treatment group requiring premature termination of beta-interferon in six patients. No differences could be stated, neither concerning recurrence-free survival nor overall survival. In the treatment group, 5-year survival of patients with side effects was 62% compared to 30% of patients without side effects, but this difference was not significant. Conclusion: In gastric cancer patients no beneficial effects of adjuvant postoperative beta-interferon therapy could be demonstrated. Due to this fact this treatment and schedule cannot be recommended as a promising approach.
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